GYNOL II EXTRA STRENGTH- nonoxynol gel 
Caldwell Consumer Health LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Nonoxynol-9 (3%) (100 mg per applicatorful)............................................Vaginal Contraceptive

Uses

For the prevention of pregnancy.

With condom or alone.

For vaginal use only.

Not for rectal (anal) use.

Sexually transmitted diseases (STDs) alert:

This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner.

Do not use if you or your sex partner has HIV/AIDS. If you do not know if your sex partner is infected, choose another form of birth control.

Stop use and ask a doctor if you or your partner gets burning, itching, a rash, or other irritation or the vagina or penis.

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Directions

For maximum protection against unwanted pregnancy, follow the enclosed directions exactly.

Each applicatorful is effective immediately and up to one hour after application.

Insert one applicatorful into the vagina prior to intercourse (see complete, illustrated directions on the package insert).

An additional applicatorful is required prior to each act of intercourse, regardless of time since last application.

Other Information

When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of catching or spreading HIV, the virus that causes AIDS.

Store at room temperature, 20° - 25° C (68° -77° F). Avoid exposure to extremes of hot or cold.

Inactive ingredients

Lactic acid, methylparaben, povidone, propylene glycol, purified water, sodium carboxymethylcellulose, sorbic acid, sorbitol solution.

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Carton Label

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Bottle Label

GYNOL II  EXTRA STRENGTH
nonoxynol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0302
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NONOXYNOL-9 (UNII: 48Q180SH9T) (NONOXYNOL-9 - UNII:48Q180SH9T) NONOXYNOL-93.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBIC ACID (UNII: X045WJ989B)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LACTIC ACID (UNII: 33X04XA5AT)  
POVIDONE K29/32 (UNII: 390RMW2PEQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:34362-0302-51 in 1 CARTON12/01/2020
1NDC:34362-0302-181 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2011
Labeler - Caldwell Consumer Health LLC (828558713)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
DPT Laboratories832224526manufacture(34362-0302) , pack(34362-0302)

Revised: 12/2020
Document Id: 3cadc6ea-8dc2-4fa2-8fdf-aebfe1378941
Set id: eaf86a36-0573-4c39-9324-88919c4d009b
Version: 7
Effective Time: 20201201
 
Caldwell Consumer Health LLC